EDQM: Updated Information on the Quality Overall Summary (Module 2)

Recommendation

1-3 July 2024
Vienna, Austria

ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis
Part of the ICH Q7 Training Courses 2024

The revision 1 of the document "Quality overall summary (QOS) template for CEP applications", which was updated in January, has been published on the EDQM website. It is intended to provide assistance for CEP applicants and was first published in 2015. It lists the individual points of the QOS of Module 2 in detail and describes their required content. The chapters and subchapters of the main section 2.3.S Substance, which are listed in the EDQM document with explanatory information, are listed below:

• 2.3.S.1 General Information
  - 2.3.S.1.3 General Properties
• 2.3.S.2 Manufacture
  - 2.3.S.2.1 Manufacturer(s) and sites involved in the entire process
  - 2.3.S.2.2 Description of Manufacturing Process and Process Controls
  - 2.3.S.2.3 Control of Materials
  - 2.3.S.2.4 Controls of Critical Steps and Intermediates
  - 2.3.S.2.5 Process Validation and/or Evaluation
• 2.3.S.3 Characterisation
  - 2.3.S.3.1 Elucidation of structure and other characteristics
  - 2.3.S.3.2 Impurities
• 2.3.S.4 Control of the Substance
  - 2.3.S.4.1 Specification / 2.3.S.4.2 Analytical Procedures
  - 2.3.S.4.3 Validation of Analytical Procedures
  - 2.3.S.4.4 Batch Analyses
  - 2.3.S.4.5 Justification of Specification
• 2.3.S.5 Reference Standards or Materials
• 2.3.S.6 Container Closure System
• 2.3.S.7 Stability
  - 2.3.S.7.1 Stability Summary and Conclusions

Furthermore, an explanatory text on the Quality Overall Summary (QOS) including electronic instructions is provided on the EDQM website, It can be accessed here.